9/24/2015. Pelvic Floor Disorders. Agenda. What is the Pelvic Floor? Pelvic Floor Problems

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1 Management of Pelvic Floor Disorders Doctor, I don t want THAT mesh! Agenda What are pelvic floor disorders (PFDs)? What are the treatment options? Expectant. Conservative. Surgical. How and when are grafts utilized in treatment of these conditions and what is "that mesh"? Patrick Nosti, MD FACOG Director, Urogynecology of Kansas City WH AA. Slide 3 of 44. August 2013 Pelvic Floor Disorders One in three women will experience a PFD in her lifetime Pelvic Floor Disorders What is the Pelvic Floor? Set of muscles, ligaments and connective tissue in the lowest part of the pelvis. Lawrence, JM, et al. Prevalence and Co-Occurrence of Pelvic Floor Disorders in Community-Dwelling Women. Obstetrics & Gynecology. 111(3). WH AA. Slide 4 of 44. August 2013 WH AA. Slide 5 of 44. August 2013 Pelvic Floor Disorders Pelvic Floor Problems Caused by weakened pelvic muscles or tears in the connective tissue. One or more symptoms: Feeling pelvic pressure or bulge in the vagina. Urine leakage (urinary incontinence). Overactive bladder ( gotta go ). Difficulty emptying the bladder. Problems having a bowel movement. Gas or stool leakage (fecal incontinence). Pelvic Floor Disorders PFD Risk Factors Age and life stage: 1 in 4 young women (20 to 39 years). Risk increases with age. Pregnancy and childbirth. Lifestyle and behaviors: Obesity and limited physical activity. Smoking. Health conditions: Stroke. Problems urinating and having a bowel movement. Pelvic injury, pelvic surgery. 1 in 4 younger women Food and Drug Administration. Information for Patients for POP, National Institute of Child Health and Human Development. Pelvic Floor Disorders. WH AA. Slide 6 of 44. August 2013 Nygaard I, et al. Prevalence of symptomatic pelvic floor disorders in US women. JAMA, 300(11), Sept Tahereh E., et al. The Frequency of Pelvic Floor Dysfunctions and their Risk Factors in Women aged Journal of Family and Reproductive Health 6(2), June WH AA. Slide 7 of 44. August

2 Pelvic Floor Disorders Types of PFDs Bladder Control Bladder control problems Pelvic organ prolapse Bowel control problems 18 million women in the U.S. have urinary incontinence 26% of women wait >5 years to discuss with health care provider Nygaard I, et al. Pelvic Floor Disorders Network. Prevalence of symptomatic pelvic floor disorders in US women. JAMA, 300(11), September Wu, Jennifer et al. Forecasting the Prevalence of Pelvic Floor Disorders. Obstet and Gynecol, 114 (6), December WH AA. Slide 8 of 44. August 2013 WH AA. Slide 9 of 44. August 2013 Bladder Control Voiding Mechanism Bladder Control Types of Urinary Incontinence Stress incontinence: Urine leaks with activities (coughing, sneezing, laughing, lifting, exercising). Urge incontinence/overactive bladder (OAB): Gotta go now sensation (urgency). Gotta go now with leakage (urge incontinence). Gotta go often (frequency). Going often during the night (nocturia). Mixed 29% Urge 22% Stress 49% National Institute of Diabetes and Digestive and Kidney Diseases. Urinary Incontinence in Women, kidney.niddk.nih.gov/kudiseases/pubs/uiwomen. National Institute of Diabetes and Digestive and Kidney Diseases. Urinary Incontinence in Women, kidney.niddk.nih.gov/kudiseases/pubs/uiwomen. WH AA. Slide 11 of 44. August 2013 WH AA. Slide 13 of 44. August 2013 Treatment Treatment Approach Type incontinence dictates treatment MIXED Treat Predominant Symptom Incontinence Urgency incontinence STRESS INCONTINENCE URGE INCONTINENCE VS. 1 st Line Management Behavioral Modifications, Physical Therapy Stress incontinence Slings/Burch Urethral Bulking 2 nd Line Medications 3 rd Line PTNS InterStim Botox 2

3 Treatment Urge Incontinence Behavioral changes Timed voids, bladder retraining Avoiding bladder irritants, fluid vol Pelvic floor exercises (i.e. Kegel) Weight loss: 8% wt loss 42% decrease UUI * Bladder Irritants * Subak NEJM 2009 Treatment Urge Incontinence Physical Therapy 25% Valsalva (i.e. pushing) instead of contracting pelvic floor muscles MIXED Treat Predominant Symptom Treatment Approach STRESS INCONTINENCE Incontinence URGE INCONTINENCE 1 st Line Management Behavioral Modifications, Physical Therapy Fowler Nuerourol Urodyn 2010 Slings/Burch Urethral Bulking 2 nd Line Medications 3 rd Line PTNS InterStim Botox Treatment Urge Incontinence Medications Anticholinergics pills, patches, & creams Ditropan, Detrol, Enablex, Sanctura, Vesicare, Toviaz Common side effects dry mouth, dry eyes, constipation, etc New class FDA approved June 2012! Myrbetriq, B3 agonist (fewer side effects) Treatment Urge Incontinence 70-80% median urge incontinence episodes Outcomes improved concomitant physical therapy 72% drug therapy alone vs. 84% with behavioral therapy Andersson rd International Conference Incontinence, Burgio JAGS

4 Treatment Urge Incontinence High discontinuation rate 2⁰ side effects and/or efficacy 12 months up to 50% don t refill prescription MIXED Treat Predominant Symptom Treatment Approach STRESS INCONTINENCE Incontinence URGE INCONTINENCE 1 st Line Management Behavioral Modifications, Physical Therapy Sexton 2011 Int J Clinical Practice Slings/Burch Urethral Bulking 2 nd Line Medications 3 rd Line PTNS InterStim Botox PTNS/Urgent PC PTNS/Urgent PC Office treatments; few side effects Video Approved FDA 2006; KS Medicare June % improvement; 55% moderate or marked improvement ⁰, efficacy = medications Initial responders maintained 3 years with monthly treatment ⁰Peters 2010 J. Urology, Peters 2009 J. Urology Peters 2013 J. Urology MIXED Treat Predominant Symptom Treatment Approach Incontinence InterStim Intertim STRESS INCONTINENCE URGE INCONTINENCE Video 1 st Line Management Behavioral Modifications, Physical Therapy Slings/Burch Urethral Bulking 2 nd Line Medications 3 rd Line PTNS InterStim Botox 4

5 InterStim InterStim InterStim Outpatient procedure under sedation; 2 steps 80% cure or improved; 47% cure 84% good response at one-year continued success at five year Schmidt 1999 J. Urology, Brazzelli 2006 J. Urology Van Kerrobroeck 2007 J. Urology MIXED Treat Predominant Symptom Treatment Approach STRESS INCONTINENCE Incontinence URGE INCONTINENCE 1 st Line Management Behavioral Modifications, Physical Therapy Slings/Burch Urethral Bulking 2 nd Line Medications 3 rd Line PTNS InterStim Botox Botox FDA approved for OAB/urgency incontinence January 2013 Botox 69% subjects improve, 65% incontinence episodes, cure 58% Average therapeutic effect 6 months ± Apostolidis 2009 Eur Urol ± Leong 2010 Urol Int. 5

6 Treatment Approach MIXED Treat Predominant Symptom Incontinence STRESS INCONTINENCE URGE INCONTINENCE 1 st Line Management Behavioral Modifications, Physical Therapy Slings/Burch Urethral Bulking 2 nd Line Medications 3 rd Line PTNS InterStim Botox Treatment Stress Incontinence Treatment Incontinence Stress Incontinence Pessary Behavioral changes Pelvic floor exercises (aka Kegel exercises) Physical Therapy aid in identification of muscles Incontinence Pessary Treatment Stress Incontinence Behavioral therapy and/or incontinence pessary ~35% 12 months Low risk interventions; 1 st line treatment option Richter ATLAS 2010 MIXED Treat Predominant Symptom Treatment Approach STRESS INCONTINENCE Incontinence URGE INCONTINENCE 1 st Line Management Behavioral Modifications, Physical Therapy Slings/Burch Urethral Bulking 2 nd Line Medications 3 rd Line PTNS InterStim Botox 6

7 Burch or MMK Historical significance requires abdominal approach, no mesh Tension Free Vaginal Tape Introduced 1996 Burch efficacy = sling Slings GOLD STANDARD Slings GOLD STANDARD Outpatient surgery 85% cure or improvement; 60% cure Minimal risks <1% risk mesh erosion <1% risk retention requiring reoperation <5% bladder injury Is this "that mesh"? Slings GOLD STANDARD Slings not generally an issue s Utilized many specialties. Complications dependent on several factors. Composition (i.e. synthetic, biologic). Indication (i.e. incontinence, prolapse, hernia, etc). Surgeon (e.g. high volume, appropriate training). That mesh Primarily associated permanent synthetic material for vaginal prolapse repair. 7

8 Slings GOLD STANDARD AUGS & SUFU Position Statement, Jan Polypropylene mesh proven safe & effective 2. It s the most extensively researched surgery for incontinence in history; >2000 studies 3. Standard of care 4. The safety and effectiveness of multi-incision sling is well established - FDA 2013 MIXED Treat Predominant Symptom Treatment Approach STRESS INCONTINENCE Incontinence URGE INCONTINENCE 1 st Line Management Behavioral Modifications, Physical Therapy Slings/Burch Urethral Bulking 2 nd Line Medications 3 rd Line PTNS InterStim Botox Periurethral Bulking Agents Periurethral Bulking Agents Office based procedure No incisions, no recovery time However, not as effective as sling procedures 70-80% cure or improvement; 40% total continence * Long term efficacy?; often requires retreatment * Kirchin 2012 Cochrane Pelvic Organ Prolapse Most common dropping of the bladder (Cystocele) What is POP? Pelvic floor muscles and ligaments become too weak to hold organs in the correct position in the pelvis. As it progresses, women can feel bulging tissue protruding through the opening of the vagina. Dropping of the rectum (Rectocele) Least common dropping of the uterus (Uterine Prolapse) Hendrix SL, et al. Pelvic organ prolapse in the Women s Health Initiative. Am J Obstet Gynecol 186(6), WH AA. Slide 29 of 44. August

9 Levels of Support Uterine prolapse = vault prolapse Cystocele = Anterior prolapse Rectocele = Posterior prolapse ~ 50% of anterior wall prolapse has an apical component Chen, Delancey 2006 Uterine Prolapse 9

10 Cystocele 10

11 Rectocele 11

12 Pelvic Organ Prolapse Symptoms of POP Pressure and heaviness in pelvic area. Bulging feeling a lump in the vagina, or lump coming out through vaginal opening. Urinary problems: Difficulty starting to urinate. Weak or spraying stream of urine. Bowel problems: Chronic straining or pushing to have bowel movements. Pelvic pain, painful sex (dyspareunia). Low back pain associated with bulge. Food and Drug Administration. Information for Patients for POP, Ellerkmann RM, et al. Correlation of symptoms with location and severity of pelvic organ prolapse. Am J Obstet Gynecol, 185(6), December WH AA. Slide 30 of 44. August 2013 What causes prolapse? Disrupted vaginal support Pregnancy/childbirth (vaginal > C- section) Chronic cough or heavy lifting Genetic factors Prior hysterectomy (especially if top of vagina not supported) Non Surgical PT Pessary Vaginal Approach Prolapse Repair Reconstructive Abdominal Approach Obliterative Colpocleisis Pelvic Organ Prolapse Treatments Best treatment depends on symptom: POP is not life-threatening. Treatments can help improve quality of life and sexual health. Conservative approach: Watch and see how things go. Pelvic floor muscle exercises. Pelvic floor physical therapy. Pessary: Support bladder, uterus and vagina. e.g. Uphold USLS or SSLF Sacrocolpoexy RAUSLS Food and Drug Administration. Information for Patients for POP, PFD Alliance. WH AA. Slide 31 of 44. August

13 Non Surgical PT Pessary Vaginal Approach Prolapse Repair Reconstructive Abdominal Approach Obliterative Colpocleisis Pelvic Organ Prolapse Treatments Most minimally invasive Specific type of surgery depends on: Anatomy. Overall health, other health problems. Prior surgeries. Desire to retain sexual function. Experience and training of surgeon. e.g. Uphold USLS or SSLF Sacrocolpoexy RAUSLS Food and Drug Administration. Information for Patients for POP, PFD Alliance. WH AA. Slide 32 of 44. August s Slings GOLD STANDARD Autologous tissue (aka native tissue, your tissue) Vs. s Biologics Allografts-cadaver skin and fascia Xenografts-porcine dermis, bovine pericardium Synthetic Mesh Polypropylene Mesh Absorbable 13

14 -s Consider grafts in following patients Increased risk of recurrence Stage of prolapse Age Environmental factors (e.g. heavy lifting at work) Previous prolapse surgery Non Surgical PT Pessary Vaginal Approach e.g. Uphold Prolapse Repair Reconstructive USLS or SSLF Abdominal Approach Sacrocolpoexy RAUSLS Obliterative Colpocleisis Vaginal Approach Uterosacral Ligament Suspension Vaginal Approach Sacrospinous Ligament Suspension Intraperitoneal TVH +/-BSO APR USLS Extraperitoneal vault prolapse APR SSLF Prolapse Repair Non Surgical PT Pessary Reconstructive Obliterative Vaginal Approach Abdominal Approach Colpocleisis e.g. Uphold USLS or SSLF THAT MESH! Sacrocolpoexy RAUSLS 14

15 Uphold Vaginal Mesh Uphold Vaginal Mesh Advantage Anterior & apical prolapse Minimal mesh No overlapping suture Uterine preserving procedure -Vaginal Mesh -Synthetic mesh Improved outcome ant. & apical prolapse, NOT posterior Advantages Improved subjective and objective outcomes Disadvantages Increased operative time Increased blood loss Mesh exposure, 10.4% Reop for exposure, 6.6% Generally risk of reoperation prolapse recurrence risk of reoperation for mesh complications Pick the lesser of two evils Maher et al, Cochrane 2012 Non Surgical PT Pessary Prolapse Repair Reconstructive Obliterative Abdominal Approach Sacrocolpopexy Not all mesh is the same Type AND the route Vaginal Approach Abdominal Approach Colpocleisis 95% cure of apical prolapse, highest cure for reconstructive surgery e.g. Uphold USLS or SSLF Sacrocolpopexy RAUSLS 1-3% risk of mesh complications Nygaard,

16 Sacral Colpopexy The Mesh Laparoscopy and Robotics da Vinci Surgical System Patient Side-Cart Surgeon Console InSite Vision System Non Surgical PT Pessary Vaginal Approach Prolapse Repair Reconstructive Abdominal Approach Obliterative Colpocleisis - Obliterative Colpocleisis >95% success for prolapse Excellent option elderly patients multiple comorbidies failure pessary or unreliable e.g. Uphold USLS or SSLF Sacrocolpoexy RAUSLS 16

17 Patient specific Goals of Alleviate symptoms & improve quality of life Optimize bladder, bowel, and coital function Restore normal anatomy How to choose a POP surgery? Patient goals Risk for recurrence Severity of POP Occupation Age Chronic increased intra-abdominal pressure Prior failed surgery Sexual activity Desires uterine preservation Risk for mesh related complications What do you recommend for patients with primary prolapse? Native tissue repair (i.e. sacrospinous, uterosacral ligament suspension, etc) recurrent prolapse? Native tissue repair or abdominal mesh/sacrocolpopexy (# previous prolapse surgeries, # abdominal surgeries, type of previous surgeries) When do you use vaginal mesh? Rarely Women with history of previous prolapse surgery Poor candidates of minimally invasive sacrocolpopxy Not sexually active Recommendations for women with prolapse or incontinence? Consult a specialist Know your options What type of prolapse do you have? Are all compartments addressed? If graft utilized know the type, route of placement and alternatives Vaginal or abdominal mesh; autologous, synthetic, or biologic; prolapse or incontinence THANK YOU 17